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Obesity, OverweightPhase 1NCT07877038

Pharmacokinetics, Safety, and Tolerability of DA-302168S Tablets in Participants With Hepatic Impairment and Normal Hepatic Function

A Phase 1 study testing DA-302168S in people with Obesity, Overweight and T2DM (Type 2 Diabetes Mellitus), run by Chendu DIAO Pharmaceutical Group CO., LTD..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is an open-label, non-randomized study to assess how DA-302168S is absorbed, distributed, metabolized, and eliminated after a single oral dose. The study includes three groups: subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), and healthy… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
DA-302168S
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
No sites listed yet
Study dates
22 Oct 2026to 7 Apr 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18-70 years inclusive at ICF signing; male or female. Age matching (±10 years) between normal hepatic function and hepatic impairment groups; sex matching as much as possible (±1 participant/sex).
  • Screening weight/BMI: males ≥50.0 kg, females ≥45.0 kg; BMI 19.0-30.0 kg/m² inclusive. Weight matching (±10 kg) between groups.
  • Women and men of childbearing potential must agree to use reliable contraception for themselves and their partners during the study and for 90 days after dosing (see Appendix 4), and must not donate sperm or eggs/oocytes for assisted reproduction.
  • Able to understand the study procedures and methods; voluntarily sign the ICF; willing to strictly follow protocol requirements and complete related procedures.
  • Normal hepatic function group:
  • No clinically significant abnormalities in screening clinical laboratory results, vital signs, 12-lead ECG, or physical examination, as judged by the investigator.
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  • No known or suspected hepatic impairment at screening; screening AST and ALT < ULN.
  • Hepatic impairment group:
  • Mild or moderate hepatic impairment by Child-Pugh classification due to viral hepatitis, alcoholic liver disease, non-alcoholic liver disease, schistosomal liver disease, or autoimmune hepatitis (excluding primary biliary cirrhosis).
  • Stable disease with no clinically significant change within 28 days before screening (e.g., no worsening of hepatic impairment symptoms, total bilirubin or prothrombin time not worsened by >20%). Note: Additional screening tests may be performed if needed; external test results may be accepted for preliminary comparison at the investigator's discretion.
  • If receiving treatment for hepatic impairment or other comorbidities before screening, treatment must have been stable for ≥4 weeks and remain stable during the study.

Who cannot join

  • History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2; or screening serum calcitonin ≥50 ng/L.
  • History of chronic pancreatitis, or acute pancreatitis within 3 months before ICF signing.
  • History of acute gallbladder disease within 3 months before ICF signing.
  • Any malignancy within 5 years before ICF signing (except basal cell carcinoma treated curatively and considered cured, and participants with prior liver cancer surgery who have been stable for ≥2 years).
  • Within 1 year before ICF signing, history of serious diseases of the cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, or endocrine systems (e.g., acute myocardial infarction, major depression, gastric ulcer, uremia).
  • As judged by the investigator, presence at screening of dysphagia, or any disease/condition that may affect drug absorption, distribution, metabolism, or excretion, such as active inflammatory bowel disease, gastrectomy, any intestinal resection, etc.
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  • Participation in any clinical trial within 3 months before screening (except signing ICF only without drug or device intervention), or last dose of investigational drug in a prior trial less than 5 half-lives before screening.
  • History of allergic diseases (e.g., asthma, urticaria, eczema/dermatitis) or known intolerance/allergy to glucagon-like peptide-1 receptor (GLP-1R) agonists.
  • Major surgery within 1 year before screening [defined as surgery on intracranial, thoracic, abdominal, pelvic, or limb organs causing major tissue trauma and requiring long-term recovery (e.g., organ transplantation, cardiac surgery, joint replacement)], or planned surgery during the study; or history of liver transplantation.
  • Severe hypoglycemia within 3 months before screening.
  • Blood donation or significant blood loss (≥400 mL) within 3 months before screening or from screening to first dosing, or planned blood donation during the study.
  • History of drug abuse within 3 years before screening (e.g., morphine, ketamine, THC acid, methamphetamine, MDMA, cocaine) or positive baseline urine drug screen.
  • Within 3 months before screening, smoking >5 cigarettes/day or habitual use of nicotine-containing products, or unable to abstain during the study.
  • History of alcohol abuse within 1 year before screening (i.e., >14 standard units/week for males, >7 for females; 1 standard unit = 14 g alcohol, e.g., 360 mL beer, 45 mL 40% spirits, or 150 mL wine), or positive baseline alcohol breath/blood test, or unable to abstain during the study.
  • Special dietary requirements and unable to accept the standardized diet.
  • Consumption of any grapefruit-rich beverages/foods within 7 days before first dosing; or unwilling to stop grapefruit-rich beverages/foods during the study.
  • Vaccination within 30 days before dosing, or planned vaccination within 30 days after dosing.
  • Unable to avoid strenuous exercise or other behaviors that may affect PK parameters from 48 h before dosing through the entire study.
  • History of needle/blood phobia, difficulty with blood collection, or inability to tolerate venipuncture.
  • Pregnant or breastfeeding women.
  • Participant is an investigator or other related study staff for this project.
  • Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.
  • History of chronic liver disease, including hepatitis, hepatitis B, or hepatitis C, or positive HBsAg/HCV antibody at screening;
  • Positive Treponema pallidum antibody;
  • Screening diastolic BP ≥90 mmHg or systolic BP ≥140 mmHg (if so, measure 2 additional times and use the mean of 3 measurements);
  • Use of any medication within 28 days or 5 elimination half-lives (whichever is longer) before first dosing, including prescription drugs, OTC drugs, herbal medicines, Chinese patent medicines, or nutritional supplements.
  • Liver cancer (except participants stable ≥2 years after prior surgery), hepatorenal syndrome, or limited life expectancy (defined as <1 year for the hepatic impairment cohort);
  • Cirrhosis with gastrointestinal bleeding within 3 months before screening that has not been treated with endoscopic ligation and sclerotherapy;
  • Active syphilis at screening [positive T. pallidum antibody plus positive TRUST or RPR], active hepatitis C [anti-HCV positive and HCV RNA positive], active hepatitis B [HBsAg positive, no antiviral treatment, and HBV DNA positive];
  • Drug-induced liver injury or acute liver injury of any cause;
  • Signs of clinically active grade 3 or 4 hepatic encephalopathy at screening;
  • Severe ascites and/or pleural effusion; if the investigator judges the participant is clinically stable, enrollment may be allowed;
  • Poorly controlled BP at screening (systolic ≥160 mmHg or diastolic ≥100 mmHg; if so, measure 2 additional times and use mean of 3 measurements); may enroll after BP is stable on medication for at least 1 week;
  • Screening ALT or AST >5× ULN; one repeat test may be allowed if needed to assess eligibility;
  • Serum alpha-fetoprotein (AFP) >20 ng/mL;
  • Abnormal prothrombin > ULN;
  • Use of albumin within 1 month before screening;
  • Use of any drug that may affect DA-302168 PK within 7 days or 5 half-lives (whichever is longer) before first dosing, including prescription, OTC, herbal, Chinese patent medicines, or nutritional supplements;
  • Use of any drug that may worsen hepatic impairment or drugs with unknown composition within 28 days or 5 half-lives (whichever is longer) before first dosing, including prescription, OTC, herbal, Chinese patent medicines, or nutritional supplements.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

xiaolong qin contact

18781997925

qinxiaolong.cn@outlook.com

About this study

Official title: A Study to Evaluate the Pharmacokinetic Characteristics, Safety, and Tolerability of DA-302168S Tablets in Trial Participants With Varying Degrees of Hepatic Impairment and in Those With Normal Hepatic Function

This is an open-label, non-randomized study to assess how DA-302168S is absorbed, distributed, metabolized, and eliminated after a single oral dose. The study includes three groups: subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), and healthy subjects matched by gender, age, and body mass index (BMI). It will also explore the relationship between baseline liver function measures and the pharmacokinetic (PK) parameters of DA-302168S, to support appropriate dosing recommendations for patients with liver impairment.

Being tested
DA-302168S
Medical subject headings
Obesity, Overweight, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DA-302168SDrug

    Small molecule GLP-1RA tablet

Study groups in NCT07877038
Study groupRoleWhat they receive
Group AExperimentalSubjects with mild hepatic impairment
Receives: Drug: DA-302168S
Group BExperimentalSubjects with moderate hepatic impairment
Receives: Drug: DA-302168S
Group CPlacebo comparatorSubjects with normal hepatic function matched to hepatic impairment subjects
Receives: Drug: DA-302168S

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak Plasma Concentration (Cmax) of DA-302168S

    Measured: Predose up to 72 hours postdose (D1 to D4)

  2. Area Under the Serum Concentration Curve From Time 0 to the Last Measurable Concentration (AUC0-last) of DA-302168S

    Measured: Predose up to 72 hours postdose (D1 to D4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2026
  2. Study start22 Oct 2026 (estimated)
  3. Primary completion7 Apr 2027 (estimated)
  4. Study completion7 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07877038
Sponsor's protocol ID
2026-CP-DA168-13
Status last verified
Oct 2026
First submitted
9 Oct 2026
Last updated
15 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DA-302168S in people with Obesity, Overweight and T2DM (Type 2 Diabetes Mellitus), run by Chendu DIAO Pharmaceutical Group CO., LTD..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact xiaolong qin (18781997925, qinxiaolong.cn@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration (Cmax) of DA-302168S (time frame: Predose up to 72 hours postdose (D1 to D4)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07877038.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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